Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment

NCT ID: NCT06279195

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-11-02

Brief Summary

The mechanisms underlying variable efficacy of Relugolix-Combination Therapy (REL-CT) in mitigating unexplained pelvic pain will be evaluated with uterine imaging techniques and quantitative sensory testing.

Detailed Description

The mechanisms underlying variable efficacy of Relugolix-Combination Therapy (REL-CT) in mitigating unexplained pelvic pain will be evaluated with real-time uterine imaging techniques and quantitative sensory testing. Advanced MRI methodology enables the assessment of various uterine parameters, including contractions, peristalsis, perfusion, blood oxygenation, and structural factors. Importantly, it is possible to temporally correlate these mechanisms with self-reported spontaneous menstrual cramping pain through real-time imaging.

In the first aim of this proposal (Aim #1), mechanisms underlying unexplained menstrual pain phenotypes linked to deficiencies in myometrial activity, perfusion, and oxygenation and evaluate the subsequent impact of REL-CT will be evaluated. Aim #2 focuses on characterizing unexplained menstrual pain phenotypes associated with impairments in the central nervous system sensory functions and the effects of REL-CT. Quantitative sensory testing methods will be used to comprehensively assesses peripheral, central ascending, central integrating, and central descending nervous system components related to pelvic pain. In the past, this testing can identify central nervous system component pain that predicts the pain trajectory and corresponds with treatment outcomes.

By analyzing the relationship between the variable effectiveness of REL-CT treatment to observed mechanisms in menstrual pain, it may possible to identify specific unexplained pelvic pain phenotypes amenable to medical management. Furthermore, because that the precise mechanisms by which REL-CT alleviates menstrual pain in endometriosis remain incompletely understood, a cohort of endometriosis patients will be also studied. The overarching objective is to uncover the underlying mechanisms that advance the comprehension of menstrual pain biology and establish these mechanisms as phenotypic markers for treating REL-CT.

Conditions

Pelvic Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Idiopathic Pelvic Pain

Participants with Idiopathic Pelvic Pain must: 1. Self-report an average non-menstrual pelvic pain rating of ≥ 4/10 (on a 0 to 10 Numeric Rating Scale) over the past 6 months. 2. Not have received a prior diagnosis attributed to a secondary cause (e.g., leiomyoma, endometriosis). Participants will be instructed to start taking Relugolix-combination therapy (40 mg of relugolix, 1 mg of estradiol, and 0.5 mg of norethindrone acetate) within 7 days of their period starting, at the same time every day for the next 6 months.

Group Type: EXPERIMENTAL

Relugolix (40 mg) /estradiol (1 mg)/norethisterone acetate (0.5 mg) oral tablet

Intervention Type: DRUG

All participants will be instructed to take REL-CT.

Endometriosis:

Participants with Endometriosis: 1. Must self-report an average non-menstrual pelvic pain rating of ≥ 4/10 (on a 0 to 10 Numeric Rating Scale) over the past 6 months. 2. Have a previously confirmed surgical diagnosis of stage III-IV endometriosis, indicating potential remission. Participants will be instructed to start taking Relugolix-combination therapy (40 mg of relugolix, 1 mg of estradiol, and 0.5 mg of norethindrone acetate) within 7 days of their period starting, at the same time every day for the next 6 months.

Group Type: EXPERIMENTAL

Relugolix (40 mg) /estradiol (1 mg)/norethisterone acetate (0.5 mg) oral tablet

Intervention Type: DRUG

All participants will be instructed to take REL-CT.

Interventions

Relugolix (40 mg) /estradiol (1 mg)/norethisterone acetate (0.5 mg) oral tablet

All participants will be instructed to take REL-CT.

Intervention Type: DRUG

Other Intervention Names

Myfembree; Relugolix Combination Therapy; REL-CT

Eligibility Criteria

Inclusion Criteria

Idiopathic pelvic pain (40 participants):

• Self-report an average non-menstrual pelvic pain rating of ≥ 2/10 (on a 0 to 10 Numeric Rating Scale) over the past 6 months.
• Not have received a prior diagnosis attributed to a secondary cause (e.g., leiomyoma, endometriosis).

Endometriosis (20 participants)

• Self-report an average non-menstrual pelvic pain rating of ≥ 2/10 (on a 0 to 10 Numeric Rating Scale) over the past
• Previously confirmed surgical diagnosis of stage III-IV endometriosis, indicating potential remission.

Exclusion Criteria

• History of blood clots,
• Allergies to REL-CT ingredients
• Diabetes
• Migraines
• Osteoporosis
• Vascular disease
• Hormone-sensitive cancers
• Smoking.
• Missing limbs
• Paralysis,
• Conditions associated with irregular menses
• Congenital conditions affecting reproductive function
• Intrauterine device use
• Pelvic inflammatory conditions
• Active genitourinary infections,
• Inability to read or comprehend the informed consent document written in English
• History of metallic implants, history of metallic injury, any condition precluding investigation with MRI
• BMI exceeding 40
• Uncontrolled thyroid dysfunction
• Adrenal dysfunction
• Renal disorders
• Liver disorders
• Coagulopathy,
• Gastrointestinal conditions or surgeries that may affect absorption

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Endeavor Health

OTHER

Sponsor Role: lead

Responsible Party

Kevin Hellman

Research Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

NorthShore University HealthSystem

Evanston, Illinois, United States

Countries

United States

References

Hellman KM, Kuhn CS, Tu FF, Dillane KE, Shlobin NA, Senapati S, Zhou X, Li W, Prasad PV. Cine MRI during spontaneous cramps in women with menstrual pain. Am J Obstet Gynecol. 2018 May;218(5):506.e1-506.e8. doi: 10.1016/j.ajog.2018.01.035. Epub 2018 Feb 2.

Reference Type: BACKGROUND

PMID: 29409786 (View on PubMed)

Kmiecik MJ, Tu FF, Silton RL, Dillane KE, Roth GE, Harte SE, Hellman KM. Cortical mechanisms of visual hypersensitivity in women at risk for chronic pelvic pain. Pain. 2022 Jun 1;163(6):1035-1048. doi: 10.1097/j.pain.0000000000002469. Epub 2021 Aug 27.

Reference Type: BACKGROUND

PMID: 34510138 (View on PubMed)

Other Identifiers

EH23-326

Identifier Type: -

Identifier Source: org_study_id